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Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether changes in germs living in the airways are linked to lung disease caused by NTM bacteria (nontuberculous mycobacteria). It is for people who may have NTM lung disease and uses mucus and airway samples; some people will also have bronchoscopy, a test that uses a thin scope to look inside the lungs.

A biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will evaluate the airway microbiome using an aliquot of the induced sputum and upper airway samples. Since induced sputum may reflect different regions of the upper/lower airways, the investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A history of lung-related symptoms, such as cough, tiredness, feeling unwell, fever, weight loss, trouble breathing, coughing up blood, or chest discomfort.
  • Chest images from the past 2 years showing certain changes: spots or hollow areas on an X-ray, or widened airways or thick airway walls with many small spots on a CT scan.

Who can't join

  • For the main study: oral antibiotics or steroids in the past month, or recent smoking. Ongoing macrolide antibiotics and inhaled steroids started more than a month before are allowed.
  • For the bronchoscopy part: a breathing test result below 70% of the expected amount of air breathed out in 1 second.
  • For the bronchoscopy part: diabetes or major heart problems, including an abnormal heart tracing, known or suspected heart artery disease, or heart failure.
  • For the bronchoscopy part: major liver or kidney disease.
  • For the bronchoscopy part: severe blood-clotting problems, defined by an INR above 1.4, a PTT above 40 seconds, and a platelet count below 150,000. These tests measure clotting and cells that help stop bleeding.
  • For the bronchoscopy part: pregnancy.
  • For the bronchoscopy part: drinking more than 6 beers or more than 4 mixed drinks each day.
  • For the bronchoscopy part: unable to understand the study and give informed consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * History of pulmonary symptoms: cough, fatigue, malaise, fever, weight loss, dyspnea, hemoptysis, or chest discomfort * Imaging abnormalities (within 2 years): defined as nodular or cavitary opacities on chest radiograph, or a computed tomography scan that shows bronchiectasis or bronchial wall thickening with associated multiple small nodules. Definition of NTM case: * Subjects that meet inclusion criteria and have culture positivity for NTM: at least two separate expectorated induced sputum samples or from one bronchoalveolar lavage (BAL) or lung biopsy Definition of NTM control: * Subjects that meet inclusion criteria and have less than two separate expectorated induced sputum samples culture negative or culture negative bronchoalveolar lavage (BAL) or lung biopsy. Exclusion Criteria for cohort study (Aim 1-2): * Recent (\<1 months prior) oral antibiotic or steroid use. (Continuous treatment with macrolides and inhaled steroids are acceptable \>1 month prior) * Recent smoking history Exclusion Criteria for bronchoscopic study (Aims 3-4): * Forced expiratory volume at one second (FEV1) \< 70%of predicted. * Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure. * Diabetes mellitus * Significant liver or renal disease * Severe coagulopathy (INR \> 1.4, Partial Thromboplastin Time (PTT) \> 40 seconds and platelet count \< 150x103 cells). * Pregnancy * Ethanol (ETOH) use of more than \>6 beers or \>4 mixed drinks daily * Lack of capacity to provide informed consent.

Study sites (1)

NY